Clinical Trial for Evaluating the Efficacy and Safety of Electrocoagulation vs Topic Sinecatechins vs Topic Cidofovir Within the Treatment to High-grade Anal Intraepithelial Neoplasia in HIV Homosexual Males

NCT ID: NCT04055142

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-18
• Study Completion Date: 2024-07-02

Brief Summary

This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN).

The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males.

All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.

Detailed Description

This Trial addresses one of the emerging problems in patients with HIV infection, such as the high incidence of anal dysplasia and anal cancer. The study proposes to evaluate new therapeutic options in the treatment of anal dysplasia, thus trying to overcome the current limitations of electrocoagulation (moderate efficacy, high recurrence, significant patient discomfort, and significant health cost).

Topical cidofovir has shown (in a non-comparative study) efficacy and tolerance rates similar to those observed for electrocoagulation, although with the benefits of self-application by the patient. This makes it an attractive topical treatment option that requires a direct comparison with the currently chosen treatment, which is electrocoagulation.

On the other hand, the medical properties of the sinecatechins, together with the results obtained in the treatment studies of oral and cervical dysplasia, and the possibility of being self, make this drug an attractive option to be evaluated experimentally in the treatment of anal dysplasia. Finally, the identification of prognostic markers of the disease should continue to be explored, in terms of the response to treatment and the recurrence of the disease.

Conditions

High-grade Anal Intraepithelial Neoplasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Electrocoagulation

This procedure will be implemented following the Standard of Care (SoC) on weeks: 0, 8 and 16 calculated since the day the patient is included into the trial.

Group Type: ACTIVE_COMPARATOR

electrocoagulation

Intervention Type: PROCEDURE

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks)

Sinecatechins (10%)

Topical ointment wich contains 2 grams of active principle (sinecatechins 10%) at each administration. It will be taken three times per week during 8 weeks of treatment.

Group Type: EXPERIMENTAL

sinecatechins 10% topical ointment

Intervention Type: DRUG

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks)

cidofovir (1%)

Topical ointment wich contains 2 grams of active principle (cidofovir 1%) at each administration. It will be taken three times per week during 8 weeks of treatment.

Group Type: EXPERIMENTAL

cidofovir 1% topical ointment

Intervention Type: DRUG

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks)

Interventions

electrocoagulation

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks)

Intervention Type: PROCEDURE

cidofovir 1% topical ointment

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks)

Intervention Type: DRUG

sinecatechins 10% topical ointment

HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks)

Intervention Type: DRUG

Other Intervention Names

Cidofovir; Veregen ointment

Eligibility Criteria

Inclusion Criteria

• Men who have sex with men, older or same than 18 years old.
• HIV-1 positive men.
• High grade anal intraepithelial neoplasia recognised by biopsy during 12 months previous to study.
• Informed consent is signed voluntarily.

Exclusion Criteria

• Patient with any disease or condition which rules him out to participate in the research, by investigator opinion.
• Treated patients for HGAIN in the previous 6 months.
• Patients with relapsed HGAIN two or more times in the last three months.
• People with learning difficulties

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital U. Vall d'Hebrón

Barcelona, Catalonia, Spain

Countries

Spain

References

Burgos J, Curran A, Garcia J, Campany D, Descalzo V, Suanzes P, Navarro J, Planas B, Sanchiz M, Landolfi S, Dinares C, Hernandez-Losa J, Falco V. Effectiveness of Electrocautery, Topical Cidofovir, and Topical Sinecatechins for the Treatment of Anal High-Grade Squamous Intraepithelial Lesions in Persons With HIV: An Open-Label, Randomized Controlled Trial. Clin Infect Dis. 2025 Sep 16;81(2):333-340. doi: 10.1093/cid/ciaf086.

Reference Type: DERIVED

PMID: 40036375 (View on PubMed)

Other Identifiers

TreatAIN

Identifier Type: -

Identifier Source: org_study_id